Basilea Pharmaceutica has received a first approval, in Canada, for its anti-MRSA broad-spectrum antibiotic ceftobiprole.

The Switzerland-based firm announced that it has obtained regulatory backing from Health Canada authorising the marketing of ceftobiprole, to be co-promoted with Johnson & Johnson unit Janssen-Ortho, and sold under the trade name Zeftera. The approval means that the drug will be the first broad-spectrum anti-MRSA antibiotic belonging to the cephalosporin class to be sold anywhere in the world.

Chief executive Anthony Man said that getting the green light in Canada is “an important advance in the fight against infections due to potentially deadly bacteria, including MRSA”. He added that the labelling “reflects our conviction that Zeftera is an innovative broad-spectrum, first-line treatment” which may be used before knowing the exact bacteria causing the infection.

The Canadian market is relatively small but Dr Man said the approval “signals the start of a new era for Basilea as we commercialise the first of a number of innovative compounds in our pipeline.” Ceftobiprole is also under review by regulators in the USA and European Union, as well as in Australia, Russia, South Africa and Switzerland.

European approval is expected later this year, while the US Food and Drug Administration is likely to give its verdict on the drug at the beginning of 2009. In March, the agency issued an approvable letter for the drug and requested more information on its impact on diabetic foot infections, as well as more time to evaluate the clinical data in the file and inspect study sites.

Importantly the FDA did not ask for any additional trials to be carried out so analysts believe a US approval looks likely and it has been widely predicted that ceftobiprole will become a blockbuster. However, the news about the Canadian approval did not send investors wild with delight and Basilea’s stock edged up less than 1% to 166.40 Swiss francs.